Viatom C10 User manual

CE-C10-03-SMSP01-20220502 V1.0
Pocket Ultrasound System C10
Instruction Manual
(V1.1N)
IMPORTANT！
Read and understand this manual before operating
the equipment. After reading, keep this manual in an
easily accessible place.

CE-C10-03-SMSP01-20220502 V1.0
Contents
Introduce........................................................................................................................................ I
Maintenance and repair service.............................................................................................III
Intellectual Property Statement..............................................................................................III
1Safety precautions.....................................................................................................................1
1.1 Security classification .....................................................................................................1
1.2 Security symbol...............................................................................................................1
1.3 Safety warning information.............................................................................................2
1.4 WARNING Labels..........................................................................................................4
1.5 Ultrasound Benefits and Risks........................................................................................4
Ultrasound Benefits...........................................................................................................4
Ultrasound Risks...............................................................................................................4
2 Product overview ...........................................................................................................................5
2.1 Intended use ........................................................................................................................5
2.2 Contraindication..................................................................................................................5
2.3 Product specifications .........................................................................................................6
2.3.1 Imaging mode........................................................................................................6
2.3.2 Power condition ....................................................................................................6
2.3.3 environment condition...........................................................................................6
2.4 system configuration........................................................................................................8
2.4.1 Standard configuration..........................................................................................8
2.4.2 Components...........................................................................................................8
Transducer Type................................................................................................................8
2.5 Symbol description...........................................................................................................9
2.6 Introduction of each component of the system ..............................................................12
2.7 Control panel..................................................................................................................13
3 Basic introduction........................................................................................................................14
3.1 Install software...............................................................................................................14
3.1.1 iPhone/iPad .........................................................................................................14
3.1.2 Android device....................................................................................................15
3.1.3 Windows device..................................................................................................15
3.2 Turn on/off the probe .....................................................................................................16
3.3 Probe and Terminal connection......................................................................................17
3.4 Basic software interface.................................................................................................21
Convex array + Phased array mode: .......................................................................................21
4 Detailed operation introduction.................................................................................................22
4.1 Introduction to all levels of menu ..................................................................................22
4.1.1 First level menu...................................................................................................22
4.1.2 Introduction to the second level menu ................................................................22
4.2 Operation Introduction...................................................................................................23
4.2.1 B mode................................................................................................................23
Selecting Exam Present...................................................................................................26
Switching Between Imaging Modes ...............................................................................27

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Image Adjustment ...........................................................................................................27
4.2.2 BM mode.............................................................................................................28
4.2.3 C mode................................................................................................................29
4.2.4 PW mode.............................................................................................................30
4.3 Measurements ................................................................................................................31
4.4 Patient’s information and report.....................................................................................32
4.5 DICOM ..........................................................................................................................33
5 maintenance and inspect ...........................................................................................................34
5.1 Charging the probe.........................................................................................................34
5.2 Replace the battery.........................................................................................................37
5.3 Cleaning and Disinfecting the probe..............................................................................38
Cleaning the probe ..........................................................................................................38
Disinfecting the probe.....................................................................................................39
5.4 Wear probe protection sleeve.........................................................................................40
5.5 Storage ...........................................................................................................................41
5.6 Inspect............................................................................................................................41
5.7 Life cycle........................................................................................................................42
5.7 Troubleshooting .............................................................................................................43

CE-C10-03-SMSP01-20220502 V1.0
Production enterprise name: Beijing Konted Medical Technology Co.,Ltd
Registered address: Room 111,1F, Building 3, No. 27, Yongwang Road,Daxing Biological
Pharmaceutical Industry Base,Daxing District,Beijing,China
Production address: Room 111,1F, Building 3, No. 27, Yongwang Road,Daxing Biological
Pharmaceutical Industry Base,Daxing District,Beijing,China
Zip code:102629
Tel: [phone]
Fax:[phone]
Customer service: Beijing Konted Medical Technology Co.,Ltd
Address: Room 111,1F, Building 3, No. 27, Yongwang Road,Daxing Biological Pharmaceutical
Industry Base,Daxing District,Beijing,China
Zip code:102629
Tel: [phone]
Fax:[phone]
Product: Pocket Ultrasound System
Model: C10
Authorized European Representative:
Party B: SUNGO Cert GmbH,Add: Harffstr. 47, 40591 Düsseldorf, GermanyCE certificate
1639

CE-C10-03-SMSP01-20220502 V1.0
I
Introduce
This manual describes the operation of the Pocket Ultrasound System. In order to ensure
the safe operation of the system, please read and understand the contents of the manual
before using the system
This specification is formulated and explained by KONTED.
This manual is published: December 2018，first revised December 2019.
KONTED reserves the right to change the contents of the instruction manual without prior
notice
Important statement!
1. The part or all of the contents of this manual shall not be copied or copied prior to the written
permission;
2. It is forbidden to modify the software or hardware of this product;
3. The utility model can provide the doctor with the image and data needed for clinical diagnosis,
and the doctor is responsible for the diagnosis process;
4. Quality assurance does not include the following, even within the warranty period：
(1) Damage or loss caused by improper installation or environmental conditions that do not
meet the requirements;
(2) Damage or loss caused by the supply voltage exceeding the specified range;
(3) Damage or loss of equipment or components purchased not from KONTED or its
authorized distributor or agent;
(4) There is no damage or loss caused by the use of this instrument in the initial purchase
area;
(5) Damage or loss caused by maintenance of non authorized personnel of the company;
(6) Damage or loss caused by force majeure such as fire, earthquake, flood or lightning;
(7) Damage or loss caused by error or rough use;
(8) Failure caused by other non product itself
5. FCC Caution:
Any Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.

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II
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
This radio is designed for and classified as “General population/uncontrolled Use”, the guidelines
are based on standards that were developed by independent scientific organizations through
periodic and thorough evaluation of scientific studies. The standards include a substantial safety
margin designed to assure the safety of all persons regardless of age or health.
Body and limbs operation; this device was tested for typical body and limbs operations kept 0mm
for body worn. To maintain compliance with RF exposure requirements, use accessories that
maintain a 0mm for body worn.
Note: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates, uses
and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
—Consult the dealer or an experienced radio/TV technician for help.

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III
Maintenance and repair service
The main warranty period is 18 months. The warranty period from the date when the
product leave the factory. Within the warranty period, the product can enjoy free customer
service; but please note that even in the warranty period, due to the reasons on the page
"important statement" caused by the products need maintenance, KONTED will charge
maintenance services, you need to pay the cost of maintenance and spare parts costs.
After the expiration of the warranty, KONTED can provide maintenance services.
It should be noted that if you do not pay or delay the payment of maintenance costs, US
will temporarily suspend maintenance services until you pay.
We hereby declare that you must familiarize yourself with the operating instructions
before use and operate and use it in strict accordance with the requirements and methods
of operation of the operating instructions. The Company does not assume any
responsibility for safety, reliability and performance assurance due to any abnormality
caused by operation, use, maintenance and storage in accordance with the requirements
of this manual.
Operation taboo:
Danger ※Do not modify this equipment, including equipment components,
software, cables and so on. User modifications may result in security problems or reduced
system performance. All modifications must be completed by the personnel approved by
KONTED.
Intellectual Property Statement
This specification and the intellectual property rights of the products are owned by
KONTED. No individual or organization may copy, modify or translate any part of this
manual without the written consent of KONTED.

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1 Safety precautions
1.1 Security classification
According to the type of anti electric shock：
Internal power supply, where the adapter is Class 1;
According to the degree of anti electric shock：
Type BF application part;
According to the protection degree of harmful liquid：
The system probe is IPX5;the probe head is IPX7
According to the degree of safety in the presence of flammable anesthetic gas mixed
with air (or oxygen, nitrous oxide two);
According to the working mode:
Continuous working equipment.
1.2 Security symbol
Security
symbol
Detailed description
Type BF application part
Description: all the ultrasonic probes are part of the BF application.
"Be careful" indicates what should be noted. Be sure to read the
instructions carefully before using the system.

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1.3 Safety warning information
In order to ensure the safety of the patient and the operator, the following safety rules
should be strictly observed in the use of the wireless ultrasonic probe.
WARNI
NG:
1.
Do not disassemble the ultrasonic probe, which may cause electric
shock.
2.
Use the power cord supplied with this unit; use only the power supply
provided by US to supply power, the use of other specific power supply
(such as UPS, etc.) on the ultrasonic probe power supply may bring the
risk of electric shock.
3.
Use the probe carefully, if the probe is scratched with the contact
surface of the human body, immediately stop using the probe and
contact the service representative. If you use a scratched probe, there
is a risk of electric shock.
4.
Every time you use the instrument must be checked for safety, do not let
the probe by the impact of damaged ultrasound probe may cause the
patient to be shocked.
5.
Before performing an ultrasound check, check the surroundings to
ensure safe use within the environment. Do not operate the unit in an
environment with flammable or explosive liquids, vapors or gases such
as oxygen or hydrogen.
6.
Be sure to wear a sterile probe case on the probe when performing an
ultrasonic chamber check.
7.
Do not immerse the ultrasonic probe Type-C USB interface or above in
water or disinfectant. Because the Type-C USB interface of the
ultrasonic probe does not have a waterproof function, this may cause an
electric shock or a probe malfunction.
8
Before and after each inspection, you must ensure that the ultrasound
sound normal. A defective ultrasonic probe may cause the patient to be
shocked.
9
If the head part of the probe does not comply with EMC requirements, it
is forbidden to use the sound head for use in the body (as the device
may be adversely affected by other equipment).

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3
CAREF
UL：
1.
Matters needing attention in clinical examination technology：
This equipment can only be operated by qualified
medical personnel.
This manual does not introduce a clinical examination
technique. It is necessary to select the correct inspection
techniques according to the professional training
knowledge and clinical experience.
2.
The equipment can not be checked for a long time.
3.
Do not use incompatible coupling agents, disinfectants, probe
protective cover, probe, puncture rack.
4.
Sterile gloves must be worn to prevent infection when using
ultrasonic probes.
5.
You must use a sterile ultrasound coupling agent. Use a coupling
agent that is in compliance with local regulatory requirements. In
addition, it is necessary to properly manage and use the
ultrasonic coupling agent to ensure that it does not become a
source of infection.
6.
The probe cover is made of natural rubber and is used with
caution for natural rubber allergy.
7.
For in vivo transducers in a single fault condition, the surface
temperature rise shall not exceed 43 °C.
CAU
TIO
N：
1
In order to prevent abnormal probe function, read the following safety
precautions:
After each ultrasonic examination, the ultrasonic coupling agent on the
surface of the probe should be thoroughly erased. Otherwise, the
ultrasonic coupling agent will be solidified on the probe head, which
will affect the quality of the ultrasound image.
The probe should be cleaned and disinfected before and after each
ultrasonic examination。
2
Ambient environmental requirements:
Please use the ultrasonic probe in the specified environment：
ambient temperature：0℃～35℃
relative humidity：30% ～85%（No condensation）
Atmospheric pressure：70KPa ～106KPa。
To prevent damage to the ultrasonic probe, do not expose the probe to
the following environment：
Place where the sun shines
A place where the temperature changes dramatically.
A place filled with dust
Easy to vibrate place
Place near the heat source
3
Repeated disinfection will lead to the safety and performance of the
probe, the performance of the probe should be regularly checked.

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1.4 WARNING Labels
The system has a variety of identification to cause the user to pay attention to the
potential danger. The symbol on the warning sign indicates the precautions for system
security.
The instructions explain in detail the meaning of these warning signs. Read the
instructions carefully before using the system.
1.5 Ultrasound Benefits and Risks
Ultrasound is widely used because it provides many clinical benefits to the patient
and has an excellent safety record. Ultrasound imaging has been used for over twenty
years and there have been no known long-term negative side effects associated with this
technology.
Ultrasound Benefits
- Portability
- Cost-effectiveness
- Multiple diagnostic uses
- Immediate results
- Safety record
Ultrasound Risks
Ultrasonic waves can heat the tissues slightly. It is normal that the probe may feel
warm to the touch while charging. If you remove the probe from the charging pad before
or immediately after charging is complete, it is recommended that you allow the probe to
cool down before use. Since the system limits patient contact temperature and will not
scan at or above 43°C (109°F), allowing the probe to cool down before use will
optimize scan time performance.

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2 Product overview
2.1 Intended use
It is designed to fulfill following intended uses: Obstetrics、Gynaecology、Abdominal
Small Parts (breast, thyroid, testicle, etc) 、Cardiology 、Peripheral Vascular 、
Muscular-Skeletal、Nerve、Urology、Orthopedic、Angiography、Physical Examinations、
Digestion、Paediatrics、Paracentesis .
2.2 Contraindication
The product is not suitable for the examination of the organs containing gas, such as
the stomach and intestines, etc. when burned, burned or damaged in the surface of the
human body, it can not be used in this part.

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2.3 Product specifications
2.3.1 Imaging mode
B mode
BM mode
C mode
PW mode
PDI mode
2.3.2 Power condition
External power adapter
Supply voltage AC : 100 - 240V
Power frequency : 50/60Hz
Output DC: 5V/2A
Internal battery
voltage: 3.8V
capacity: 2600mAh
2.3.3 environment condition
work environment
Storage and transportation
environment
ambient
temperature
0℃～40℃
0℃～+45℃
relative
humidity
30%～85%
（No condensation）
30%～95%
（No condensation）
atmospheric
pressure
70KPa～106KPa
70KPa～106KPa

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WARNI
NG：
Transport:
1. Do not use or store the system outside the specified
environmental conditions.
Working:
1. Please ensure that the use of the equipment to master a solid,
otherwise, equipment may hurt the patient fall.
2. To ensure that the equipment in a dry environment, the
operation of environmental temperature and humidity changes,
may lead to liquid condensation in the circuit board, there is the
risk of short circuit.
3. Do not operate the unit in an environment with flammable or
explosive liquids, vapors or gases such as oxygen or hydrogen.
Equipment failure or fan motor sparks may be electronically
detonated of these substances.
A. Please ensure that the environment before use, if the
detection of flammable substances in the environment, please do
not plug in the power or open the system.
B. Use the real-time detection environment to detect flammable
substances after the system is turned on. Do not attempt to turn
off the device or unplug the power supply. First empty the air in
the area and ensure a smooth ventilation and then turn off the
power.
4. If the system fails, please do not disassemble the view, please
contact the service center or your sales representative.

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2.4 system configuration
The system is mainly composed of probe and application.
2.4.1 Standard configuration
Main unit probe: 1 set
Type-C Cable: 1 set
Wireless charger: 1 set
Black handbag：1 set
Plug:American Standard or British Standard Plug
Accessory: Operation manual
2.4.2 Components
Transducer Type
Transducer
model
Type of
Transducer
Intended use
Applicable
site
Wireless
charging
C10
3 in 1 type
Gynecology and obstetrics, abdominal
kidney，Small organ, carotid artery, Msk,
Cardiac
body surface
√

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2.5 Symbol description
This device uses the following symbol identification, the following list shows its meaning.
Serial
number
Symbol
Explain
1
Type BF application part
explain：All ultrasonic probes are part of the BF
application.
2
Please refer to the instruction manual for this symbol to
avoid accidents
3
Indicates the product serial number
4
Indicates the manufacture.
5
IPX 7
The 7 indicates that the system is protected against the
effects of immersion in water to depth between 15 cm and
1 meter.
6
Safety mark on behalf of the product has been in line with
European standards for safety / health / environmental /
health and other standards and directives
7
Indicates the date of manufacture.
8
Indicates that the device must be collected separately for
disposal. Follow proper disposal procedures.
9
Authorized European Representative:
Shanghai International Holding Corp. GmbH(Europe)
Eiffestraβe 80, 20537 Hamburg Germany
10
Indicates the reference or catalog number
11
Non-ionizing electromagnetic radiation
12
Model number

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Serial
number
Symbol
Explain
13
Country of manufacture
14
Importer
15
Distributor
16
Medical device
17
UDI
18
Power
Voltage
Frequency
19
Class II equipment
20
Away from the sunlight
21
Storage temperature limit
22
Upwards

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Serial
number
Symbol
Explain
23
Keep dry
24
Storage humidity limit
25
Stacking layer limit

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2.6 Introduction of each component of the
system
number
Name
Function
1
Control buttons
Power switch / freeze /Living button
2
USB Type-C port
Connect to Android/Windows software/Charging
with USB type-C cable
3
Battery status
Battery charge/remaining display
4
SN
Serial number; password of this probe’s wifi
5
Wireless charging symbol
Face to wireless charger
6
Convex probe
= Convex probe + Phased probe
7
Linear probe
Linear probe
8
Type-C cable
Connect to Android/Windows software/Charging
with USB type-C cable
9
Fast Charger
The wireless charging pad
1
2
3
6
4
5
7
8
9

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2.7 Control panel
Control
buttons
Button
icon
Key name
Function
Power switch /
freeze / thaw
button
1）When the probe is not turned on, press the
key to open the probe;
2）When the probe is in the open state, press
the key to close the probe;
3）When the probe is in the scanning state,
press the key to freeze the screen image;
4) In the frozen state, press the button to thaw
the screen image, the probe continues to scan
the image.
5) Press and hold for 3 seconds to switch the
scanning mode(Convex array probe/linear array
probe)
Press the button and hold for 3 seconds to switch the scanning mode
(Convex array probe ↔linear array probe)